Gastroenterology-Urology Devices; Manual Gastroenterology-Urology Surgical Instruments and Accessories, 12171 [2017-03997]
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Federal Register / Vol. 82, No. 39 / Wednesday, March 1, 2017 / Rules and Regulations
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and redelegated to the Center for
Veterinary Medicine, and in accordance
with § 514.116 Notice of withdrawal of
approval of application (21 CFR
514.116), notice is given that approval
of NADA 135–773 and ANADA 200–
421, and all supplements and
amendments thereto, is hereby
withdrawn, effective March 13, 2017.
Elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to reflect the voluntary
withdrawal of approval of these
applications.
Dated: February 23, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–03931 Filed 2–28–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. FDA–2016–N–4661]
Gastroenterology-Urology Devices;
Manual Gastroenterology-Urology
Surgical Instruments and Accessories
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
The Food and Drug
Administration (FDA) is amending the
identification of manual
gastroenterology-urology surgical
instruments and accessories to reflect
that the device does not include
specialized surgical instrumentation for
use with urogyencologic surgical mesh
specifically intended for use as an aid
in the insertion, placement, fixation, or
anchoring of surgical mesh during
urogynecologic procedures
(‘‘specialized surgical instrumentation
for use with urogynecologic surgical
mesh’’). These amendments are being
made to reflect changes made in the
recently issued final reclassification
order for specialized surgical
instrumentation for use with
urogynecologic surgical mesh.
DATES: This rule is effective March 1,
2017.
FOR FURTHER INFORMATION CONTACT:
Sharon Andrews, Center for Devices and
Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, Rm. G110,
Silver Spring, MD 20993, 301–796–
6529, Sharon.Andrews@fda.hhs.gov.
jstallworth on DSK7TPTVN1PROD with RULES
SUMMARY:
VerDate Sep<11>2014
14:27 Feb 28, 2017
Jkt 241001
FDA is
amending § 876.4730 (21 CFR 876.4730,
Manual gastroenterology-urology
surgical instrument and accessories), by
adding language to the identification of
the device to reflect that specialized
surgical instrumentation for use with
urogynecologic surgical mesh is no
longer regulated under § 876.4730.
In the Federal Register of November
23, 1983 (48 FR 53012), FDA issued a
final rule classifying manual
gastroenterology-urology surgical
instrument and accessories into class I
under § 876.4730 (48 FR 53012 at
53025). Certain specialized surgical
instrumentation for use with
urogynecologic surgical mesh was
regulated as class I devices under that
regulation. In the Federal Register of
January 6, 2017 (82 FR 1598), FDA
issued a final order reclassifying
specialized surgical instrumentation for
use with urogynecologic surgical mesh
from class I (general controls) exempt
from premarket notification to class II
(special controls) and subject to
premarket notification. As a result of
that final reclassification order, FDA is
amending the identification at
§ 876.4730(a) to reflect that specialized
surgical instrumentation for use with
urogynecologic surgical mesh is now
regulated under 21 CFR 884.4910.
FDA finds good cause for issuing this
amendment as a final rule without
notice and comment because this rule
only updates the identification of the
device under § 876.4730 to reflect
changes made in the recently issued
final reclassification order for
specialized surgical instrumentation for
use with urogynecologic surgical mesh
(5 U.S.C. 553(b)(B)). In addition, FDA
finds good cause for this amendment to
become effective on the date of
publication of this action. The
Administrative Procedure Act allows an
effective date less than 30 days after
publication as ‘‘provided by the agency
for good cause found and published
with the rule’’ (5 U.S.C. 553(d)(3)). A
delayed effective date is unnecessary in
this case because the amendment to
§ 876.4730 does not impose any new
regulatory requirements on affected
parties. As a result, affected parties do
not need time to prepare before the rule
takes effect. Therefore, FDA finds good
cause for this amendment to become
effective on the date of publication of
this action.
SUPPLEMENTARY INFORMATION:
List of Subjects in 21 CFR Part 876
Gastroenterology-urology devices,
Medical devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
PO 00000
Frm 00005
Fmt 4700
Sfmt 4700
12171
of Food and Drugs, 21 CFR part 876 is
amended as follows:
PART 876—GASTROENTEROLOGYUROLOGY DEVICES
1. The authority citation for part 876
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Amend § 876.4730 by revising
paragraph (a) to read as follows:
■
§ 876.4730 Manual gastroenterologyurology surgical instrument and
accessories.
(a) Identification. A manual
gastroenterology-urology surgical
instrument and accessories is a device
designed to be used for
gastroenterological and urological
surgical procedures. The device may be
nonpowered, hand-held, or handmanipulated. Manual gastroenterologyurology surgical instruments include the
biopsy forceps cover, biopsy tray
without biopsy instruments, line clamp,
nonpowered rectal probe, nonelectrical
clamp, colostomy spur-crushers, locking
device for intestinal clamp, needle
holder, gastro-urology hook, gastrourology probe and director, nonselfretaining retractor, laparotomy rings,
nonelectrical snare, rectal specula,
bladder neck spreader, self-retaining
retractor, and scoop. A manual surgical
instrument that is intended specifically
for use as an aid in the insertion,
placement, fixation, or anchoring of
surgical mesh during urogynecologic
procedures are classified under
§ 884.4910 of this chapter.
*
*
*
*
*
Dated: February 23, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–03997 Filed 2–28–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–436]
Schedules of Controlled Substances:
Placement of 10 Synthetic Cathinones
Into Schedule I
Drug Enforcement
Administration, Department of Justice.
ACTION: Final rule.
AGENCY:
With the issuance of this final
rule, the Drug Enforcement
Administration places 10 synthetic
SUMMARY:
E:\FR\FM\01MRR1.SGM
01MRR1
]]>Agencies
[Federal Register Volume 82, Number 39 (Wednesday, March 1, 2017)]
[Rules and Regulations]
[Page 12171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03997]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. FDA-2016-N-4661]
Gastroenterology-Urology Devices; Manual Gastroenterology-Urology
Surgical Instruments and Accessories
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the
identification of manual gastroenterology-urology surgical instruments
and accessories to reflect that the device does not include specialized
surgical instrumentation for use with urogyencologic surgical mesh
specifically intended for use as an aid in the insertion, placement,
fixation, or anchoring of surgical mesh during urogynecologic
procedures (``specialized surgical instrumentation for use with
urogynecologic surgical mesh''). These amendments are being made to
reflect changes made in the recently issued final reclassification
order for specialized surgical instrumentation for use with
urogynecologic surgical mesh.
DATES: This rule is effective March 1, 2017.
FOR FURTHER INFORMATION CONTACT: Sharon Andrews, Center for Devices and
Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. G110,
Silver Spring, MD 20993, 301-796-6529, Sharon.Andrews@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is amending Sec. 876.4730 (21 CFR
876.4730, Manual gastroenterology-urology surgical instrument and
accessories), by adding language to the identification of the device to
reflect that specialized surgical instrumentation for use with
urogynecologic surgical mesh is no longer regulated under Sec.
876.4730.
In the Federal Register of November 23, 1983 (48 FR 53012), FDA
issued a final rule classifying manual gastroenterology-urology
surgical instrument and accessories into class I under Sec. 876.4730
(48 FR 53012 at 53025). Certain specialized surgical instrumentation
for use with urogynecologic surgical mesh was regulated as class I
devices under that regulation. In the Federal Register of January 6,
2017 (82 FR 1598), FDA issued a final order reclassifying specialized
surgical instrumentation for use with urogynecologic surgical mesh from
class I (general controls) exempt from premarket notification to class
II (special controls) and subject to premarket notification. As a
result of that final reclassification order, FDA is amending the
identification at Sec. 876.4730(a) to reflect that specialized
surgical instrumentation for use with urogynecologic surgical mesh is
now regulated under 21 CFR 884.4910.
FDA finds good cause for issuing this amendment as a final rule
without notice and comment because this rule only updates the
identification of the device under Sec. 876.4730 to reflect changes
made in the recently issued final reclassification order for
specialized surgical instrumentation for use with urogynecologic
surgical mesh (5 U.S.C. 553(b)(B)). In addition, FDA finds good cause
for this amendment to become effective on the date of publication of
this action. The Administrative Procedure Act allows an effective date
less than 30 days after publication as ``provided by the agency for
good cause found and published with the rule'' (5 U.S.C. 553(d)(3)). A
delayed effective date is unnecessary in this case because the
amendment to Sec. 876.4730 does not impose any new regulatory
requirements on affected parties. As a result, affected parties do not
need time to prepare before the rule takes effect. Therefore, FDA finds
good cause for this amendment to become effective on the date of
publication of this action.
List of Subjects in 21 CFR Part 876
Gastroenterology-urology devices, Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
876 is amended as follows:
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES
0
1. The authority citation for part 876 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Amend Sec. 876.4730 by revising paragraph (a) to read as follows:
Sec. 876.4730 Manual gastroenterology-urology surgical instrument
and accessories.
(a) Identification. A manual gastroenterology-urology surgical
instrument and accessories is a device designed to be used for
gastroenterological and urological surgical procedures. The device may
be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-
urology surgical instruments include the biopsy forceps cover, biopsy
tray without biopsy instruments, line clamp, nonpowered rectal probe,
nonelectrical clamp, colostomy spur-crushers, locking device for
intestinal clamp, needle holder, gastro-urology hook, gastro-urology
probe and director, nonself-retaining retractor, laparotomy rings,
nonelectrical snare, rectal specula, bladder neck spreader, self-
retaining retractor, and scoop. A manual surgical instrument that is
intended specifically for use as an aid in the insertion, placement,
fixation, or anchoring of surgical mesh during urogynecologic
procedures are classified under Sec. 884.4910 of this chapter.
* * * * *
Dated: February 23, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-03997 Filed 2-28-17; 8:45 am]
BILLING CODE 4164-01-P
